A Randomized, Open Label, Multicenter, Phase II Trial Comparing The Conventional 3 Weekly Schedule Of Cabazitaxel With A Weekly Regimen In Patients With Metastatic Castration Resistant Prostate Cancer
ConCab compares the standard treatment of cabazitaxel 25 mg/m2 every three weeks with an
experimental scheduling of 10 mg/m2 for 5 consecutive weeks of a 6 week cycle. In both study
arms the planned cumulative dose of cabazitaxel at week 18 is 150 mg/m2. Our study aims to
evaluate differences in the total received dose in relation to the planned dose as a measure
of which of the 2 treatment schedules is superior.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Relative cumulative dose of cabazitaxel at week 18
The primary endpoint compares the cumulative dose of cabazitaxel that is received relative to the planned dose at 18 weeks of therapy. The cumulative dose of cabazitaxel in relation to the expected dose is a reflection of both tolerability and efficacy. Patients stopping treatment due to disease progression prior to week 18 will have lower relative cumulative doses as will patients with poor tolerability due to dose reductions and delays.
week 18 after start of treatment
Jeffrey R Yachnin, MD, PhD
Karolinska University Hosptial
Sweden: Medical Products Agency